Community Translations

Filgrastim-sndz debuts as the first biosimilar approved in United States


 

In March this year, filgrastim-sndz became the first biosimilar to receive approval from the US Food and Drug Administration for use in the United States. Biosimilars are biological products that show comparable quality, efficacy, and safety to a reference drug that is already approved. In this case, filgrastim-sndz, by Sandoz, a Novartis company, is a biosimilar of Amgen’s filgrastim, the reference drug or originator, which is already licensed in the United States for 5 indications, including for cancer patients undergoing treatments that deplete white blood cells, as well as those preparing for autologous peripheral blood stem-cell transplant, or those with severe, chronic neutropenia.1
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